MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PERITONEAL CATHETER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number	50-9000B
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that: there was a yellowish substance.Verbatim: describe the event or problem.In special procedures: item number 50-9000b-pentoneal pleurx catheter kit (carefusion) was opened to prep for pleurx placement procedure.When product was opened, there was a yellowish substance on the end of the connecting tube that connects to the pleurx catheter.This kit was removed from the sterile field and sterile field was re-prepped and a new pleurx kit was opened.The same yellowish substance was in the same place, but on a newly opened package.This product was also discarded.A third item was opened on a sterile environment that was set up away from the large sterile tray.This pleurx kit did not have the yellowish substance.
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that: there was a yellowish substance.Verbatim: in special procedures: item number 50-9000b-pentoneal pleurx catheter kit (carefusion) was opened to prep for pleurx placement procedure.When product was opened, there was a yellowish substance on the end of the connecting tube that connects to the pleurx catheter.This kit was removed from the sterile field and sterile field was re-prepped and a new pleurx kit was opened.The same yellowish substance was in the same place, but on a newly opened package.This product was also discarded.A third item was opened on a sterile environment that was set up away from the large sterile tray.This pleurx kit did not have the yellowish substance.
Event or Problem Description
It was reported that : there was a yellowish substance describe the event or problem.In special procedures: item number 50-9000b-pentoneal pleurx catheter kit (carefusion) was opened to prep for pleurx placement procedure.When product was opened, there was a yellowish substance on the end of the connecting tube that connects to the pleurx catheter.This kit was removed from the sterile field and sterile field was re-prepped and a new pleurx kit was opened.The same yellowish substance was in the same place, but on a newly opened package.This product was also discarded.A third item was opened on a sterile environment that was set up away from the large sterile tray.This pleurx kit did not have the yellowish substance.I have both connecting tubes from the kits m the office.The company for this pleurx catheter kit is being notified.
Additional Manufacturer Narrative
Pr 4013315 follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001423488 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer here.

• Brand Name: PLEURX PERITONEAL CATHETER KIT
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12983874
• Report Number: 1625685-2021-00100
• Device Sequence Number: 12176439
• Product Code: PNG
• UDI-Device Identifier: 10885403075957
• UDI-Public: (01)10885403075957
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K160437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 50-9000B
• Device Catalogue Number: 50-9000B
• Device Lot Number: 0001423488
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown